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A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin (PAINS)

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ClinicalTrials.gov Identifier: NCT00892008
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : November 18, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:
This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.

Condition or disease Intervention/treatment
Neuropathic Pain Drug: Pregabalin

Study Type : Observational
Actual Enrollment : 2278 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Group/Cohort Intervention/treatment
Open-Label
This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.
Drug: Pregabalin
Pregabalin 75-150 mg BID for at least 2 weeks.
Other Name: Lyrica




Primary Outcome Measures :
  1. Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) [ Time Frame: Baseline through Final Visit (Week 4) ]
  2. Discontinuations Due to Adverse Events [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]

Secondary Outcome Measures :
  1. Change From Baseline in Visual Analogue Scale (VAS) Score [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  2. VAS Pain Score at Baseline (BL) and Second Visit [ Time Frame: Baseline, Second Visit (Week ≥ 2) ]
  3. VAS Pain Score at Baseline and Final Visit [ Time Frame: Baseline, Final Visit (Week 4) ]
  4. Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  5. Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  6. Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  7. Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  8. Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  9. Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female, 18 years and above diagnosed with neuropathic pain.
Criteria

Inclusion Criteria:

  • Male or female, 18 years old and above diagnosed with neuropathic pain.

Exclusion Criteria:

  • Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892008


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00892008     History of Changes
Other Study ID Numbers: A0081094
First Posted: May 1, 2009    Key Record Dates
Results First Posted: November 18, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by Pfizer:
pregabalin
neuropathic pain
safety

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs